Psycho-emotional distress in children and adolescents in relation to COVID-19 confinement and pandemic: A systematized review : Author lists.

A stressor such as a pandemic is a trigger to focus on the study of the psycho-emotional impact on children and adolescents from a nursing care perspective. The aim of this systematized review was to know the impact of the lockdown and COVID-19 pandemic on children (from 2 to 12 years) and adolescent (from 13 to 18 years) in relation to daily routines, as well as the most frequent psycho-emotional manifestations. The research was carried out following PRISMA guidelines and was performed using several databases (PubMed, Scopus and Cochrane). The search was focused on children and adolescent population between 2020 and 2021.The literature search was from November to December 2021. Sixteen articles were used to perform the systematized review. A disruption in daily routines and an increase in psycho-emotional manifestations have been observed in young people, which is understood as a worsening of their psycho-emotional integrity. Higher levels of anxiety and depression in adolescents and hyperactivity and dependence disorders in the children have also been reported. In conclusion, children and adolescents have been affected in the psycho-emotional sphere in the same way as adults, therefore, it is necessary to know the presenting characteristics of this group of people in order to be able to establish an effective nursing approach and help preserve the mental integrity, as well as promote resilience.

Wellbeing and Complementary Therapies in Breast Cancer Peripheral Neuropathy Care: A Scoping Review Focused on Foot Health.

BACKGROUND: Chemotherapy-induced peripheral neuropathy is a multidimensional health problem. Up to now, little evidence has been found concerning its impact on quality of life and foot health. Evaluation tools and prevention and treatment strategies must be reported. This study aimed to map the literature on the impact of this side effect on the wellbeing and foot health of people with breast cancer and to describe their main assessment strategies and complementary therapies. METHODS: A scoping review was carried out while following the PRISMA-ScR and Arksey and O'Malley guidelines. Different databases (Cochrane Plus, Scopus, Web of Science, and Pubmed) were used. A total of 221 results were identified. Sixteen articles were included. RESULTS: The thematic analysis obtained the following categories: the impact of peripheral neuropathy on quality of life and foot health, complementary therapies as a path for new strategies, and the need for clinicians and researchers to get involved in researching this side effect. CONCLUSIONS: Peripheral neuropathy has a negative impact on people's quality of life. Implications for foot health and maintaining an active and healthy lifestyle have not been previously reported. Complementary therapies are recommended by scientific evidence, highlighting exercise. However, there is a need to develop more research that will help to incorporate them into evidence-based practice.

Influence of Nutrition Status and Compression Therapy on Venous Ulcer Healing: A Systematic Review.

OBJECTIVE: To review the literature to determine whether compression therapies and nutrition status influence venous ulcer healing. DATA SOURCE: A systematized bibliographic review was carried out by searching PubMed, Scopus, and Cochrane databases for studies published between 2015 and 2020, using descriptors in Spanish and English. STUDY SELECTION: After establishing the research question and applying the filters based on inclusion and exclusion criteria, 114 articles were found. After screening, 11 articles were selected for the review: 8 were identified in the literature search, and 3 were added from the bibliographic references of other studies. DATA EXTRACTION: The authors developed a data extraction sheet that recorded the following variables: author, country, year of publication, level of evidence, research design, therapy type, initial ulcer size, active ulcer history, pain, healed wounds, wound reduction, therapy tolerance, nutrition assessment method, body mass index, and nutrition disorders. DATA SYNTHESIS: Four studies analyzed the relationship between nutrition status and venous ulcer healing, finding that these patients tend to have a high body mass index; a deficit of nutrients such as vitamin A, D, or zinc; and an excess of lipids and carbohydrates. Seven studies compared different types of compression to determine which provided the best results, with two- and four-layer therapy being the most commonly used. Variables such as small wound size and recent onset were associated with better prognosis. CONCLUSIONS: In terms of nutrition, the parameters analyzed are very limited. Although several studies show that two-layer therapy produces the greatest ulcer healing, there is not enough information to recommend one type of therapy over the other. Therefore, more clinical trials are needed to study broader nutrition parameters and compare the types of therapy under matched conditions to determine their influence on ulcer healing.

Incidence of COVID-19 in Children and Young People Who Play Federated Football.

AIM: To determine the incidence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection in children and young people who play federated football. METHODS: Prospective study, from October 2020 to January 2021, in players aged 4 to 19 years from federated football clubs in Galicia, Spain (N = 23,845). Outbreaks and cases of SARS-CoV-2 infection were recorded. The cumulative incidence was compared with the incidence registered in Galicia in the same age range. RESULTS: The cumulative incidence was 29.8 cases per 10,000 licenses in 4 months, lower than the incidence registered in the general population for all ages and both sexes (283.7 per 10,000 inhabitants; rate ratio = 9.5). It was higher in January (40.7 per 10,000), coinciding with the population peak. More cases were registered in futsal (42.9 vs 27.5 per 10,000) and competitions with periodic screenings (127.4 vs 9.1 per 10,000). There were 2 outbreaks in 2389 teams (0.08%). CONCLUSION: The results support the safety of football practice in children and young people with prevention protocols.

Concordance between Pressure Platform and Pedigraph.

OBJECTIVES: Determine the concordance between two methods of obtaining the plantar footprint (pedigraph and pressure platform). METHODS: A descriptive, cross-sectional, observational study of prevalence was carried out in the social center of Cariño (Coruña), Spain (n = 65 participants). Older people without amputations or the presence of dysmetria were included. The variables studied were: sociodemographic (age, sex), anthropometric (body mass index) and footprint measurement variables. These measurements were made by obtaining the plantar footprint using two methods: pedigraph and pressure platform. RESULTS: The mean age of the sample was 37.42 ± 15.05 years, with a predominance of the female gender (61.54%). Positive linear correlation between pedigraph and platform was observed in both feet in the Chippaux and Staheli indices (correlation coefficient > 0.3, p < 0.001 in each comparison). The reliability was good or moderate in relation with the Chippaux and Staheli index. Slightly lower coefficients were observed in the dimensions of the foot. CONCLUSIONS: A positive linear correlation between pedigraph and platform was observed in both feet in the Chippaux and Staheli indices. Significant differences were observed between pedigraph and platform in relation to the width and length of the foot. It is probably due to the fact that the pressure platform provides more exhaustive, detailed and accurate information of the foot.

Pain assessment and management in the newborn: A systematized review.

BACKGROUND: Neonatal pain has been underdiagnosed due to several false beliefs. AIM: To determine the status of neonatal pain in newborns who are admitted to intensive care units. METHODS: Different databases were searched. Literature reviews and research reports conducted in newborns that were written in English, Spanish, or Portuguese, published between 2010 and 2020, and having free access to the full text were selected. A total of 135 articles were found, and 18 articles were finally reviewed. RESULTS: Newborns are exposed to numerous painful procedures. In order to assess their pain levels, several scales have been used, although they are sometimes not correctly interpreted. In terms of pain management, the nursing team plays a very important role based mainly on both pharmacological and non-pharmacological approaches. CONCLUSION: Nursing staff members must be well trained in order to identify pain and to interpret the scales correctly. Besides, they have an important role in performing non-pharmacological procedures for pain management.

Sexual Dysfunction in Ostomized Patients: A Systematized Review.

The impact of an ostomy has a negative influence on sexuality. Healthcare professionals focus the care on surgery, and consider the sexual life is little relevant to the patient recovery. The aim of this systematized review is to give visibility to the sexual problems that ostomy patients have, to know what kind of sexual dysfunction occurs in this patients, to give information to the nursing staff about sexual disturbances and to recommend some resources to restart sexual activity. The research was conducted following de PRISMA guidelines and performed in several databases. Twelve papers were used to perform the systematized review. After ostomy, sexual dysfunction is different in men and women. It is related by the psychological aspects (low self-esteem, body image deterioration, etc.), the physical aspects (type of resection, complications, etc.) and the acceptance by the partner. A personalized sexual education focused on sexual problems that appear in ostomy patients is necessary to implement. In this way, adequate support, information and resources before and after surgery could be given for both, patients and their partners.

Randomized clinical trial to determine the effectiveness of CO-oximetry and anti-smoking brief advice in a cohort of kidney transplant patients who smoke.

Background: measure the efficacy of exhaled carbon monoxide (CO) measurement plus brief advisory sessions to reduce smoking exposure and smoking behaviour in kidney transplant recipients. Methods: Randomized, controlled, open-label clinical trial at a Spanish hospital.Smoking kidney transplant recipients giving their consent to participate were randomized to control (brief advice, n=63) or intervention group (brief advisory session plus measuring exhaled CO, n=59). Measurements: Sociodemographic characteristics, cardiovascular risk factors, treatment, rejection episodes, infections, self-reported smoking, drug use, level of dependence and motivation to stop smoking (Fagerström's and Richmond's test) and stage of change (Prochaska and DiClemente's Stages). Efficacy was assessed at 3, 6, 9 and 12 months as: cotinine test, CO levels in exhaled air, nicotine dependence, motivational stages of change, motivation to stop smoking, pattern of tobacco use and smoking cessation rates. Logistic regression models were computed. Results: At 12 months of follow-up, differences were found in exhaled CO between the intervention and control group(6.1±6.8vs.10.2±9.7ppm;p=0.028). Carboxyhemoglobin levels were lower in the intervention group as well as the positive cotinine test (1.2±1.2%vs.2.0±2.4%;p=0.039),(53.4%vs.74.2%). At 12 months, intervention reduces the probability of a positive urine test by 28%. Conclusions: Co-oximetry is a clinically relevant intervention for reduction of tobacco exposure in kidney transplant recipients.

Characterisation of long-term cancer survivors and application of statistical cure models: a protocol for an observational follow-up study in patients with colorectal cancer.

BACKGROUND: Improved colorectal cancer (CRC) survival rates have been reported over the last years, with more than half of these patients surviving more than 5 years after the initial diagnosis. Better understanding these so-called long-term survivors could be very useful to further improve their prognosis as well as to detect other problems that may cause a significant deterioration in their health-related quality of life (HRQoL). Cure models provide novel statistical tools to better estimate the long-term survival rate for cancer and to identify characteristics that are differentially associated with a short or long-term prognosis. The aim of this study will be to investigate the long-term prognosis of CRC patients, characterise long-term CRC survivors and their HRQoL, and demonstrate the utility of statistical cure models to analyse survival and other associated factors in these patients. METHODS: This is a single-centre, ambispective, observational follow-up study in a cohort of n = 1945 patients with CRC diagnosed between 2006 and 2013. A HRQoL sub-study will be performed in the survivors of a subset of n = 485 CRC patients for which baseline HRQoL data from the time of their diagnosis is already available. Information obtained from interviews and the clinical records for each patient in the cohort is already available in a computerised database from previous studies. This data includes sociodemographic characteristics, family history of cancer, comorbidities, perceived symptoms, tumour characteristics at diagnosis, type of treatment, and diagnosis and treatment delay intervals. For the follow-up, information regarding local recurrences, development of metastases, new tumours, and mortality will be updated using hospital records. The HRQoL for long-term survivors will be assessed with the EORTC QLQ-C30 and QLQ-CR29 questionnaires. An analysis of global and specific survival (competitive risk models) will be performed. Relative survival will be estimated and mixture cure models will be applied. Finally, HRQoL will be analysed through multivariate regression models. DISCUSSION: We expect the results from this study to help us to more accurately determine the long-term survival of CRC, identify the needs and clinical situation of long-term CRC survivors, and could be used to propose new models of care for the follow-up of CRC patients.

Trasplante renal de donante vivo ABO incompatible. Estudio de 48 pacientes tras desensibilización / ABO-incompatible living-donor kidney transplantation: Study of 48 patients after desensitisation

ANTECEDENTES: El trasplante renal de donante vivo ABO incompatible era considerado una contraindicación absoluta. Desde hace años, se realiza con buenos resultados. OBJETIVO: Nuestro objetivo es mostrar los resultados de este tipo de trasplante realizado en nuestro hospital. MÉTODOS: Estudiamos 48 pacientes con una edad media de 50,9 ± 10,9 años. Seguimiento 44,6 ± 30,9 meses. Acondicionamiento: rituximab 375mg/m2, tacrolimus, micofenolato mofetilo o micofenolato sódico, prednisona, plasmaféresis/inmunoadsorción e inmunoglobulina intravenosa. Títulos de isoaglutininas aceptados para trasplantar: IgG e IgM inferiores a 1:8. RESULTADOS: Isoaglutininas preproceso: IgG 1:124 ± 1:140, IgM 1:77 ± 1:55. Tras 6 ± 3 sesiones, la IgG descendió a < 1:8 en 47 pacientes, a<1:16 en uno; la IgM fue < 1:8 en todos. Veinticuatro pacientes (50%) presentaron hematoma, 7 reintervención (14,6%) y 29 (60%) necesitaron transfusión. Al quinto año presentaron rechazo agudo 5 pacientes (8,7%), CMV 9 (19,7%), viremia BK 5 (12,4%), diabetes postrasplante 10 (23,4%), linfocele 3 (6,4%). La supervivencia del paciente fue del 97,1% al quinto año y la del injerto, del 95,7% al año y del 93% al quinto año. Pérdida de injerto: trombosis (n = 1), rechazo mixto (n = 1) y exitus (n=2). La creatinina al año y a los 3 años fue de 1,4 ± 0,4 mg/dl y de 1,3 ± 0.3 mg/dl al quinto año. La proteinuria al año, a los 3 y a los 5 fue de 0,2 ± 0,2 g/24 h. CONCLUSIONES: El trasplante renal de donante vivo ABO incompatible tras acondicionamiento con rituximab, plasmaféresis/inmunoadsorción e inmunoglobulinas es una opción válida y ofrece excelentes resultados de supervivencia, con una baja incidencia de rechazo agudo sin aumento de complicaciones infecciosas. Se evidencia una mayor tendencia al sangrado postoperatorio

BACKGROUND: ABO-incompatible living-donor kidney transplantation was regarded as an absolute contraindication. However, it has been carried out for years with good outcomes. OBJECTIVE: Our aim was to show the results obtained with this technique in our hospital. METHODS: Forty-eight patients with a mean age of 50.9 ± 10.9 years were included. Follow-up was 44.6 ± 30.9 months. Conditioning: rituximab 375 mg/m2, tacrolimus, mycophenolate mofetil or mycophenolate sodium, prednisone, plasmapheresis/immunoadsorption and intravenous immunoglobulin. Accepted IgG and IgM titres for transplantation: < 1:8. RESULTS: Pre-process IgG titre 1:124 ± 1:140, IgM titre 1:77 ± 1:55. After 6 ± 3 sessions, IgG decreased to < 1:8 in 47 patients and to < 1:16 in one. IgM was < 1:8 in all cases. Twenty-four patients (50%) had haematoma, 7 re-intervention (14.6%), 29 (60%) required transfusion. At 5 years, acute rejection had occurred in 5 cases (8.7%), CMV infection in 9 (19.7%), BK viraemia in 5 (12.4%), post-transplant diabetes in 10 (23.4%) and lymphocele in 3 (6.4%). Patient survival was 97.1% at 5 years and graft survival 95.7% at one year and 93% at 5 years. Causes of graft loss: thrombosis (n = 1); mixed rejection (n = 1); and death (n = 2). Serum creatinine levels were 1.4 ± 0.4 mg/dl at one and 3 years and 1.3 ± 0.3 mg/dl at 5 years. Proteinuria was 0.2 ± 0.2 g/24 h at one, 3 and 5 years. CONCLUSIONS: ABO-incompatible living-donor kidney transplantation after conditioning with rituximab, plasmapheresis/immunoadsorption and immunoglobulins is a valid option offering excellent outcomes. There is a low incidence of acute rejection and no increase in infectious complications. An increased tendency for postoperative bleeding was found

ABO-incompatible living-donor kidney transplantation: Study of 48 patients after desensitisation. / Trasplante renal de donante vivo ABO incompatible. Estudio de 48 pacientes tras desensibilización.

BACKGROUND: ABO-incompatible living-donor kidney transplantation was regarded as an absolute contraindication. However, it has been carried out for years with good outcomes. OBJECTIVE: Our aim was to show the results obtained with this technique in our hospital. METHODS: Forty-eight patients with a mean age of 50.9±10.9 years were included. Follow-up was 44.6±30.9 months. Conditioning: rituximab 375mg/m2, tacrolimus, mycophenolate mofetil or mycophenolate sodium, prednisone, plasmapheresis/immunoadsorption and intravenous immunoglobulin. Accepted IgG and IgM titres for transplantation:<1:8. RESULTS: Pre-process IgG titre 1:124±1:140, IgM titre 1:77±1:55. After 6±3 sessions, IgG decreased to<1:8 in 47 patients and to<1:16 in one. IgM was<1:8 in all cases. Twenty-four patients (50%) had haematoma, 7 re-intervention (14.6%), 29 (60%) required transfusion. At 5 years, acute rejection had occurred in 5 cases (8.7%), CMV infection in 9 (19.7%), BK viraemia in 5 (12.4%), post-transplant diabetes in 10 (23.4%) and lymphocele in 3 (6.4%). Patient survival was 97.1% at 5 years and graft survival 95.7% at one year and 93% at 5 years. Causes of graft loss: thrombosis (n=1); mixed rejection (n=1); and death (n=2). Serum creatinine levels were 1.4±0.4mg/dl at one and 3 years and 1.3±0.3mg/dl at 5 years. Proteinuria was 0.2±0.2g/24h at one, 3 and 5 years. CONCLUSIONS: ABO-incompatible living-donor kidney transplantation after conditioning with rituximab, plasmapheresis/immunoadsorption and immunoglobulins is a valid option offering excellent outcomes. There is a low incidence of acute rejection and no increase in infectious complications. An increased tendency for postoperative bleeding was found.

Hallux valgus in a random population in Spain and its impact on quality of life and functionality.

The aim of this study was to determine the prevalence of Hallux valgus (HV) and the association between the presence thereof and quality of life, dependence for basic and instrumental activities of daily living and foot function. Prevalence study was carried out in a random population sample (n = 1837) (α = 0.05; Precision = ±2.2%). Informed consent and ethical review board were obtained (code 2008/264). We studied anthropometric variables, Charlson Comorbidity Index, function and state of foot [Foot Function index (FFI), Foot Health Status Questionnaire (FHSQ)], quality of life (SF-36), and dependence for activities of daily living (Barthel and Lawton index). Degree of HV was determined using Manchester scale. Descriptive and multivariate logistic regression analyses were performed. Hence, the prevalence of HV is 39%. Patients with HV are significantly older (64.6 ± 11.7 vs 60.1 ± 12.6 years old). HV prevalence is greater in females (48.1 vs. 28.3%), subjects with flat foot (48.1 vs. 36.1%) or hammer toes (48.2 vs. 30.9%). Moreover, with regard to the presence or not of HV, statistically significant differences were neither noted in the SF-36 questionnaire nor in the Barthel and Lawton Index. For FHSQ and FFI questionnaires, significant differences were observed between patients who presented HV and those who did not. HV is associated with age, gender, flat foot and hammer toes. The SF-36 and Barthel and Lawton questionnaires remained unaltered by the presence of HV. The presence of Hallux valgus was associated with reduced quality of life and increases foot pain, disability and functional limitation.

Flat Foot in a Random Population and its Impact on Quality of Life and Functionality.

INTRODUCTION: Flat foot is a common deformity in adults. It is characterized by medial rotation and plantar flexion of the talus, eversion of the calcaneus, collapsed medial arch and abduction of the forefoot. AIM: The aim of this study was to determine the prevalence of flat foot and its impact on quality of life, dependence, foot pain, disability and functional limitation among random population of 40-year-old and above. MATERIALS AND METHODS: A cross-sectional study in a random population sample from Cambre (A Coruña-Spain) (n=835) was performed (α =0.05; Precision=±3.4%). The diagnosis of flat foot was stablished by the study of the footprint obtained with a pedograph. Anthropometric variables were studied, Charlson's Comorbidity Index, function and state of foot (Foot Function Index (FFI), Foot Health Status Questionnaire (FHSQ)), quality of life (SF-36), and dependence for activities of daily living (Barthel and Lawton index). A logistic and linear multiple regression analysis was performed. RESULTS: The prevalence of flat foot was 26.62%. Patients with flat foot were significantly older (65.73±11.04 vs 61.03±11.45-year-old), showed a higher comorbidity index (0.92±1.49 vs 0.50±0.98), had a greater BMI (31.45±5.55 vs 28.40±4.17) and greater foot size (25.16±1.66 vs 24.82±1.65). The presence of flat foot diminishes the quality of life, as measured by the FHSQ, and foot function, measured by the FFI. The presence of flat foot does not alter the physical and mental dimension of the SF-36 or the degree of dependence. CONCLUSION: Flat foot was associated with age, Charlson's Comorbidity Index, BMI and foot size. The SF-36, Barthel and Lawton questionnaires remained unaltered by the presence of flat foot. The FHSQ and FFI questionnaires did prove to be sensitive to the presence of flat foot in a significant manner.

Incidence of cardiovascular events and associated risk factors in kidney transplant patients: a competing risks survival analysis.

BACKGROUND: The high prevalence of cardiovascular risk factors among the renal transplant population accounts for increased mortality. The aim of this study is to determine the incidence of cardiovascular events and factors associated with cardiovascular events in these patients. METHODS: An observational ambispective follow-up study of renal transplant recipients (n = 2029) in the health district of A Coruña (Spain) during the period 1981-2011 was completed. Competing risk survival analysis methods were applied to estimate the cumulative incidence of developing cardiovascular events over time and to identify which characteristics were associated with the risk of these events. Post-transplant cardiovascular events are defined as the presence of myocardial infarction, invasive coronary artery therapy, cerebral vascular events, new-onset angina, congestive heart failure, rhythm disturbances, peripheral vascular disease and cardiovascular disease and death. The cause of death was identified through the medical history and death certificate using ICD9 (390-459, except: 427.5, 435, 446, 459.0). RESULTS: The mean age of patients at the time of transplantation was 47.0 ± 14.2 years; 62% were male. 16.5% had suffered some cardiovascular disease prior to transplantation and 9.7% had suffered a cardiovascular event. The mean follow-up period for the patients with cardiovascular event was 3.5 ± 4.3 years. Applying competing risk methodology, it was observed that the accumulated incidence of the event was 5.0% one year after transplantation, 8.1% after five years, and 11.9% after ten years. After applying multivariate models, the variables with an independent effect for predicting cardiovascular events are: male sex, age of recipient, previous cardiovascular disorders, pre-transplant smoking and post-transplant diabetes. CONCLUSIONS: This study makes it possible to determine in kidney transplant patients, taking into account competitive events, the incidence of post-transplant cardiovascular events and the risk factors of these events. Modifiable risk factors are identified, owing to which, changes in said factors would have a bearing of the incidence of events.

A randomized clinical trial to determine the effectiveness of CO-oximetry and anti-smoking brief advice in a cohort of kidney transplant patients who smoke: study protocol for a randomized controlled trial.

BACKGROUND: The cardiovascular risk in renal transplant patients is increased in patients who continue to smoke after transplantation. The aim of the study is to measure the effectiveness of exhaled carbon monoxide (CO) measurement plus brief advisory sessions, in comparison to brief advice, to reduce smoking exposure and smoking behavior in kidney transplant recipients who smoke. The effectiveness will be measured by: (1) abandonment of smoking, (2) increase in motivation to stop smoking, and (3) reduction in the number of cigarettes smoked per day. DESIGN: a randomized, controlled, open clinical trial with blinded evaluation. SCOPE: A Coruña Hospital (Spain), reference to renal transplantation in the period 2012-2015. INCLUSION CRITERIA: renal transplant patients who smoke in the precontemplation, contemplation or preparation stages according to the Prochaska and DiClemente's Stages of Change model, and who give their consent to participate. EXCLUSION CRITERIA: smokers attempting to stop smoking, patients with terminal illness or mental disability that prevents them from participating. RANDOMIZATION: patients will be randomized to the control group (brief advisory session) or the intervention group (brief advisory session plus measuring exhaled CO). The sample target size is n = 112, with 56 patients in each group. Allowing for up to 10 % loss to follow-up, this would provide 80 % power to detect a 13 % difference in attempting to give up smoking outcomes at a two-tailed significance level of 5 %. MEASUREMENTS: sociodemographic characteristics, cardiovascular risk factors, treatment, rejection episodes, infections, self-reported smoking habit, drug use, level of dependence (the Fagerström test), stage of change (Prochaska and DiClemente's Stages of Change model), and motivation to giving up smoking (the Richmond test). RESPONSE: the effectiveness will be evaluated every 3, 6, 9 and 12 months as: pattern of tobacco use (self-reported tobacco use), smoking cessation rates, carbon monoxide (CO) levels in exhaled air measured by CO-oximetry, urinary cotinine tests, nicotine dependence (Fagerström test), motivational stages of change (Prochaska and DiClemente's stages) and motivation to stop smoking (the Richmond test). ANALYSIS: descriptive statistics and linear/logistic multiple regression models will be performed. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat. ETHICS: informed consent of the patients and Ethical Review Board was obtained (code 2011/061). DISCUSSION: Tobacco is a modifiable risk factor that increase the risk of morbidity and mortality in kidney transplant recipients. If effectiveness of CO-oximetry is confirmed to reduce tobacco exposure, we would have an intervention that is easy to use, low cost and with great implications about cardiovascular risk prevention in these patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN16615772 . EudraCT number: 2015-002009-12.

Diagnostic and treatment delay, quality of life and satisfaction with care in colorectal cancer patients: a study protocol.

BACKGROUND: Due to recent improvements in colorectal cancer survival, patient-reported outcomes, including health-related quality of life and satisfaction with care, have become well-established endpoints to determine the impact of the disease on the lives of patients.The aim of this study is to determine prospectively, in a cohort of colorectal cancer incident cases: a) health-related quality of life, b) satisfaction with hospital-based care, and c) functional status. A secondary objective is to determine whether diagnostic/therapeutic delay influence quality of life or patients' satisfaction levels. METHODS/DESIGN: Single-centre prospective follow-up study of colorectal cancer patients diagnosed during the period 2011-2012 (n = 375).This project was approved by the corresponding ethics review board, and informed consent is obtained from each patient. After diagnosis, patients are interviewed by a trained nurse, obtaining information on sociodemographic characteristics, family history of cancer, first symptoms, symptom perception and reaction to early symptoms. Quality of life is assessed with the EORTC QLQ-C30 and QLQ-CR29 questionnaires, and patients' satisfaction with care is determined using the EORTC IN-PATSAT32. Functional status is measured with the Karnofsky Performance Status Scale.Clinical records are also reviewed to collect information on comorbidity, tumour characteristics, treatment, hospital consultations and exploratory procedures.Symptoms-to-diagnosis interval is defined as the time from the date of first symptoms until the cytohistological confirmation of cancer. Treatment delay is defined as the time between diagnosis and surgical treatment.All the patients will be followed-up for a maximum of 2 years. For survivors, assessments will be re-evaluated at one and two years after the diagnosis.Multiple linear/logistic regression models will be used to identify variables associated with the patients' functional status, quality of life and satisfaction with care score. Changes in quality of life over time will be analysed with linear mixed-effects regression models. DISCUSSION: The results will provide a deeper understanding of the impact of colorectal cancer from a more patient-centred approach, allowing us to identify groups of patients in need of additional attention, as well as areas for improvement. Special attention will be given to the relationship between diagnostic/therapeutic delay and patients' quality of life and satisfaction with the care received.

Incidence of cardiovascular events after kidney transplantation and cardiovascular risk scores: study protocol.

BACKGROUND: Cardiovascular disease (CVD) is the major cause of death after renal transplantation. Not only conventional CVD risk factors, but also transplant-specific risk factors can influence the development of CVD in kidney transplant recipients. The main objective of this study will be to determine the incidence of post-transplant CVD after renal transplantation and related factors. A secondary objective will be to examine the ability of standard cardiovascular risk scores (Framingham, REGICOR, SCORE, and DORICA) to predict post-transplantation cardiovascular events in renal transplant recipients, and to develop a new score for predicting the risk of CVD after kidney transplantation. METHODS/DESIGN: Observational prospective cohort study of all kidney transplant recipients in the A Coruna Hospital (Spain) in the period 1981-2008 (2059 transplants corresponding to 1794 patients). The variables included will be: donor and recipient characteristics, chronic kidney disease-related risk factors, pre-transplant and post-transplant cardiovascular risk factors, routine biochemistry, and immunosuppressive, antihypertensive and lipid-lowering treatment. The events studied in the follow-up will be: patient and graft survival, acute rejection episodes and cardiovascular events (myocardial infarction, invasive coronary artery therapy, cerebral vascular events, new-onset angina, congestive heart failure, rhythm disturbances and peripheral vascular disease). Four cardiovascular risk scores were calculated at the time of transplantation: the Framingham score, the European Systematic Coronary Risk Evaluation (SCORE) equation, and the REGICOR (Registre Gironi del COR (Gerona Heart Registry)), and DORICA (Dyslipidemia, Obesity, and Cardiovascular Risk) functions. The cumulative incidence of cardiovascular events will be analyzed by competing risk survival methods. The clinical relevance of different variables will be calculated using the ARR (Absolute Risk Reduction), RRR (Relative Risk Reduction) and NNT (Number Needed to Treat). The ability of different cardiovascular risk scores to predict cardiovascular events will be analyzed by using the c index and the area under ROC curves. Based on the competing risks analysis, a nomogram to predict the probability of cardiovascular events after kidney transplantation will be developed. DISCUSSION: This study will make it possible to determine the post-transplant incidence of cardiovascular events in a large cohort of renal transplant recipients in Spain, to confirm the relationship between traditional and transplant-specific cardiovascular risk factors and CVD, and to develop a score to predict the risk of CVD in these patients.

Cancer incidence in kidney transplant recipients: a study protocol.

BACKGROUND: Different publications show an increased incidence of neoplasms in renal transplant patients. The objective of this study is to determine the incidence of cancer in the recipients of renal transplants performed in the A Coruña Hospital (Spain) during the period 1981-2007. METHODS/DESIGN: During the study period 1967 kidney transplants were performed, corresponding to 1710 patients. Patients with neoplasms prior to the transplant will be excluded (n = 38). A follow-up study was carried out in order to estimate cancer incidence after transplantation.For each patient, information included donor and recipient characteristics, patients and graft survival and cancer incidence after transplantation. Incident cancer is considered as new cases of cancer after the transplant with anatomopathological confirmation. Their location will be classified according to the ICD-9.The analysis will be calculated using the indirect standardisation method. Age-adjusted cancer incidence rates in the Spanish general population will be obtained from the Carlos III Health Institute, the National Epidemiology Centre of the Ministry of Science and Technology. Crude first, second and third-year post-transplantation cancer incidence rates will be calculated for male and female recipients. The number of cases of cancer at each site will be calculated from data in the clinical records. The expected number of cancers will be calculated from data supplied by the Carlos III Health Institute. For each tumour location we will estimate the standardized incidence ratios (SIRs), using sex-specific cancer incidence rates, by dividing the incidence rate for the transplant patients by the rate of the general population. The 95% confidence intervals of the SIRs and their associated p-values will be calculated by assuming that the observed cancers follow a Poisson distribution. Stratified analysis will be performed to examine the variation in the SIRs with sex and length of follow-up.Competing risk survival analysis methods will be applied to estimate the cumulative incidence of cancer and to identify variables associated to its occurrence. DISCUSSION: Information about cancer incidence in kidney transplant patients could be useful to adapt the guidelines on post-kidney transplant follow-up on tumour screening, and evaluate the impact of intervention measures for the prevention of cancer in these patients.